Women in the UK will be able to purchase Gina 10 mg vaginal tablets without prescription from September from their local pharmacies, announced the Medicines
and Healthcare products Regulatory Agency (MHRA).
The Hormone Replacement Therapy (HRT) product, Gina 10 microgram vaginal tablets (containing estradiol) are used for the treatment of vaginal symptoms such as
dryness, soreness, itching, burning and uncomfortable sex caused by oestrogen deficiency in postmenopausal women aged 50 years and above who have not had a period
for at least one year.
The decision to reclassify these vaginal tablets follows a safety review by the MHRA, independent advice from the Commission on Human Medicines (CHM), and a public
consultation.
The UK regulator sought views from patients, pharmacists, prescribers and a wide range of stakeholders including the Royal College of Obstetricians & Gynaecologists,
the Faculty of Sexual & Reproductive Healthcare, the British Pharmacopoeia Commission and the British Menopause Society.
Any prescription for Promethazine hydrochloride 10mg tablets x 56 submitted for payment to the NHSBSA for July 2022 will be reimbursed at the new price of
£17.77 not as per the price concession of £13.45 announced in the 4th concessions update published on 29 July 2022, said the Pharmaceutical Services Negotiating
Committee (PSNC).
In July 2022, PSNC received several reports from contractors unable to obtain Promethazine hydrochloride 10mg tablets (56) at the published Drug Tariff price of
£4.24.
Therefore, it submitted a request for a price concession, which was granted and subsequently published but this was later withdrawn after confirmation from the
Department of Health and Social Care (DHSC) that due to the price change mechanism, the reimbursement price for Promethazine hydrochloride 10mg tablets has
increased from £4.24 to £17.77 for July 2022.
PSNC said, "Following the price change mechanism rules, for generic drugs (excluding drugs in Category M), a price change up to and including the 8th of the month
takes effect for prescriptions dispensed in that same month. Any price change after the 8th takes place in the following month."
The Department of Health and Social Care (DHSC) published a notification regarding the shortage of Guanfacine 2mg and 3mg modified-release tablets has
raised concerns within the healthcare community.
This critical medicine supply notification, issued on March 28th, projects the unavailability of these tablets until the week commencing May 6, 2024.
Guanfacine tablets, commonly prescribed to alleviate symptoms of hyperactivity and impulsivity while enhancing attention and concentration, play a vital role in
managing conditions like attention deficit hyperactivity disorder (ADHD).
However, the scarcity of these specific strengths poses challenges for patients reliant on this medication.
Last year, several countries across the globe experienced shortages of medications for the treatment of attention deficit hyperactivity disorder (ADHD)including
the UK, the US and Australia.
Community Pharmacy England (CPE) has cautioned that while alternative strengths of Guanfacine remain accessible, they may not adequately meet the heightened demand,
potentially resulting in treatment interruptions for patients.
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Considering the shortage of Fluoxetine 10mg tablets, the Department of Health and Social Care (DHSC) has extended the serious shortage protocol (SSP) for the medicine to February 11, 2022.
Earlier the SSP for Fluoxetine 10mg tablets was set to expire on November 12.
Extension of the transition period will enable use of No Cheaper Stock Obtainable (NCSO) endorsement and use of EPS tokens to claim for supplies made in accordance
with SSPs.
The NHS Business Services Authority (NHSBSA) has accepted that either the new 'SSP' or existing 'NCSO' endorsement for any SSP claims can be submitted using electronic prescriptions (EPS) tokens of FP10 paper prescriptions, during the period.
The Medicines and Healthcare Products Regulatory Agency (MHRA) is considering the reclassification of Aquiette 2.5mg tablets contains oxybutynin hydrochloride that is used to treat women with milder symptoms of overactive bladder from Prescription-Only-Medicine (POM) to Pharmacy (P) medicine.
The agency is encouraging pharmacists, GPs and other health care professionals, the public and women to take part in the reclassification consultation to make a
treatment for overactive bladder available for women without the need for a prescription.
Public consultation on a set of proposals to make Aquiette 2.5mg tablets (oxybutynin hydrochloride) available from pharmacies will close on 13 May, 2022.
It would be the first time a medicine for the treatment of overactive bladder would be available without prescription, if the reclassification consultation receives positive responses.
After the decision is made to reclassify this treatment, pharmacists will have access to training materials and a checklist to enable them to identify women who can be supplied this medicine safely.
The Medicines and Healthcare products Regulatory Agency (MHRA) has advised healthcare professionals to stop supplying a specific batch of Paroxetine 40mg Film Coated Tablets immediately.
Crescent Pharma Limited is recalling a specific batch of Paroxetine 40mg Film Coated Tablets as a precautionary measure due to out of specification results for dissolution during routine stability testing.
"Quarantine all remaining stock of the said batch and return it to your supplier, using your supplier's approved process," said MHRA.
The agency alerted the patients that this is a precautionary Pharmacy and Wholesaler level recall, therefore no further action is required by patients.
Pfizer has recalled all stocks of Accupro - including 5mg, 10mg, 20mg, 40mg film-coated tablets - as a precautionary measure due to the identification of a
nitrosamine above the acceptable limit.
"Following testing, N-nitroso-quinapril, has been observed at a level above the acceptable limit. Nitrosamines may increase the risk of cancer if people are
exposed to them above acceptable levels and over long periods of time. The recall is at pharmacy and wholesaler level," the Pharmaceutical Services Negotiating
Committees (PSNC) reported.
The Department of Health and Social Care (DHSC) said: "All strengths of quinapril (Accupro) tablets have been recalled with a resupply date to be confirmed. Pfizer
are the sole supplier of quinapril tablets in the UK. Alternative ACE inhibitors remain available and can support an uplift in demand."
Kelso Pharma, the growing UK based specialty pharma business, has announced its first product launch with the release to the UK prescription medicines market
of Acepiro (Acetylcysteine) 600mg effervescent tablets.
Acepiro 600 mg effervescent tablets are indicated in adults only and are being made available to hospital and community prescribers in 20 and 30 day packs, with the
30 day pack consistent with monthly prescribing. The NHS List Price for the 30 day pack is £4.40, with the 20 day pack priced at £3.65.
Acepiro is being launched by Stirling Anglian Pharmaceuticals (SAP), which was acquired by Kelso Pharma one year ago, providing a new UK platform and springboard for
future sales growth for the business. The new product complements SAP's existing portfolio of three medicines:
CosmoCol (macrogol 3350 plus electrolytes) powder for oral solution - an osmotic laxative indicated for the treatment of chronic constipation and faecal impaction.
Stirlescent (naproxen) 250mg effervescent tablets - containing naproxen, which is a non-steroidal anti-inflammatory drug (NSAID).
Superdrug Online Doctors has made travelling easy ahead of Easter by introducing jet lag 'melatonin' tablets into its travel services portfolio to help those
taking long haul flights.
The company has seen an 287 per cent increase in demand for its travel services and products. Malaria treatment is up by 272 per cent, gut health products up by
317 per cent, jet lag melatonin tablets increasing by 900 per cent since launch and Period Delay services which offer more choice when it comes to the timing of
periods up by 195 per cent year-on-year.
Dr Sara Kayat, Superdrug's medical ambassador, comments: "Jet lag is a temporary sleep problem that affects people who travel across different time zones. It can
occur when your internal clock, the function that lets your body know when to stay awake and when to sleep, is disrupted by a new time zone and puts your internal
clock out of sync. Melatonin is a hormone we produce to help regulate our sleep cycles, and a synthetic version can be taken in the short term to manage jet lag."
Advanz Pharma, alongside London-based private equity firms Cinven and HgCapital, is collectively confronted with an £84 million penalty for inflating the
price of the thyroid drug by over 1,000 per cent, soaring from £20 to £248 per package over an eight-year period.
The Competition Appeal Tribunal endorsed 'all key aspects' of the Competition and Markets Authority's verdict on the companies' culpability in the case, the CMA has
said.
Advanz stood as the sole supplier of liothyronine tablets, essential for treating thyroid hormone deficiency, with the cost of a packet of these tablets surging over
12-fold between 2009 and 2017.
Although Advanz Pharma currently possesses ownership of the company, its former owners, PE firms Cinven and HgCapital, also bear responsibility for the imposed fine,
the CMA said.
"NHS annual spending on the tablets in 2006, the year before the implementation of the strategy, was £600,000, but by 2009 had increased to more than £2.3 million
and jumped to more than £30 million by 2016," Britain's competition watchdog said.
The price concession for Atorvastatin 80mg has been increased to £3.91 from the previously set £3.45 for prescriptions dispensed in July, the Community Pharmacy
England has said. The Department of Health and Social Care additionally introduced a concession price of £3.38 for Atorvastatin 20mg.
"In July, our Dispensing and Supply Team experienced an unusually high influx of reports from pharmacies struggling to acquire Atorvastatin 80mg tablets at the
listed Drug Tariff price," said CPE.
CPE requested a price concession early in the month. However, after extended discussions, an agreement on the price wasn't reached. Consequently, on July 31st, the
DHSC imposed a concession of £3.45.
Addressing enduring pharmacy concerns over the pricing, CPE intensified advocacy with DHSC. This endeavour resulted in the revision of the Atorvastatin 80mg tablet
concession price to £3.91 for prescriptions submitted and dispensed in July.
According to CPE, this adjusted price sufficiently covers costs as reported by the majority of pharmacy owners.
However, DHSC has refrained from modifying concessionary prices for the other two requested lines by CPE. DHSC communicated that their team's data collection for
July, employing real-time sales and volume data, was incongruent with the adjustment of these prices, CPE further said.
Bambuterol 10mg tablet, used in the treatment of asthma and chronic obstructive pulmonary disease, is facing supply disruption as sole supplier of the medicine, Astra Zeneca, is discontinuing its production, according to an update by the Department of Health and Social Care (DHSC).
The available stock of the medicine is expected to be exhausted by the end of June 2022.
Meanwhile, other oral β2-agonists, which are the preferred route of administration, remain available, DHSC said.
The Department of Health and Social Care have retrospectively granted a concessionary price for Isocarboxazid 10mg tablets for the months of May and June 2021.
While the reimbursement price had previously been £217.75, a concessionary price of £249.10 has now been granted.
The NHS Business Services Authority confirmed that payment for the difference - £31.35 for every pack of 56 claimed - will be adjusted accordingly for the mentionedtime period where contractors have submitted claims in those months. This adjustment will be paid on 31 December 2021 in the next Schedule of Payments.
The Community Pharmacy England has raised a concern on pricing and availability of Atorvastatin tablets.
CPE is In discussions with the Department of Health and Social Care (DHSC) and have warned about the serious impact this issue is now having on pharmacies.
The issue was highlighted after a number of pharmacy owners have got in touch with CPE about the pricing and availability of Atorvastatin tablets.
The association said: "The DHSC Supply Team has been working closely with manufacturers and wholesalers on this issue.
Thank you to those of you who have taken the time to report the increased prices that you have purchased at.
In its first, the National Institute for Health and Care Excellence has recommended the use of long-acting injectable treatment for HIV-1 infection in adults, making around 13,000 people eligible for treatment with cabotegravir with rilpivirine in England.
The new treatment aims to keep the number of virus particles in the blood so low that it cannot be detected or transmitted between people.
Current treatment for HIV‑1 is lifelong antiretroviral tablets taken each day.
Use of cabotegravir with rilpivirine is recommended when there is no evidence tosuspect viral resistance, and no previous failure of other anti-HIV-1 medicines.
"Clinical trial results show that cabotegravir with rilpivirine is as effective as oralantiretrovirals at keeping the viral load low," NICE stated.
Both are administered as two separate injections every two months, after an initial oral (tablet) lead-in period.
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on plans to reclassify a locally-applied hormone replacement
therapy product to treat the cause and relieve the symptoms of vaginal atrophy.
The MHRA is proposing that Gina 10 microgram vaginal tablets, containing oestradiol, be made available over the counter as a "self care" product, under the
supervision of a pharmacist.
The Commission on Human Medicines too has advised that the application by Novo Nordisk, which is used to treat vaginal dryness, caused by oestrogen deficiency in
postmenopausal women, can be made available as a pharmacy (P) medicine.
The MHRA has been asking GPs, pharmacists and members of the public for their opinions on whether the tablets can be made available to women aged 50 and over who
have not had a period for at least a year.
If the reclassification goes ahead, pharmacists will be given training materials and a checklist to help them supply the medicine safely.
The Department of Health and Social Care (DHSC) has redetermined the December 2023 concessionary prices for four medicines following requests made by
Community Pharmacy England (CPE) on behalf of community pharmacy owners.
For Ezetimibe 10mg tablets (pack size 28), the price has been fixed at £17.78, up from £9.44.
Other drugs included in the list are Aripiprazole 5mg (£8.52), Digoxin 125microgram (£3.70) and Digoxin 250micrgram (£3.70) tablets.
Contractors would be reimbursed at the new prices only for prescriptions submitted for payment for the dispensing month of December 2023.
CPE said they are still working with DHSC to agree price concessions for January.
Check the final the December 2023 price concessionary here.
Additionally, DHSC on Friday confirmed that there's now sufficient stock of Clarithromycin 125mg/5ml oral suspension to meet normal demand, and the Serious
Shortage Protocol (SSP), SSP053 for the antibiotic expires on 12 January 2024.
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